Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

Randomized Controlled Trial: Single Balloon Catheter Versus Dinoprostone Vaginal Insert for Induction of Labour of Women With a BMI Equal to or Greater Than 30

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01962831

Enrollment

Registered

2013-10-14

Start date

2013-10-31

Completion date

2016-06-30

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Induced, Obesity, Pregnancy

Keywords

obesity, labor, induced, pregnancy, cervical ripening, dinoprostone

Brief summary

The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.

Interventions

DRUGDinoprostone

DEVICESingle balloon foley catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Obese (BMI \>30 before 20 weeks gestational age) * Singleton pregnancy * Vertex presentation * Bishop Score \<6 * Intact membranes * Gestational age 37+0 to 42+0 * Normal fetal heart tracing on admission for ripening

Exclusion criteria

* Induction of labour for intrauterine fetal demise * Intrauterine growth restriction * Suspected abruption at the start of induction * Any contraindication for a vaginal delivery

Design outcomes

Primary

Measure	Time frame
Time(hours) from initiation of induction of labour to vaginal delivery	Will be assessed at the end of each vaginal delivery

Secondary

Measure	Time frame
Number of cesarean sections in each group	2 years
Number of operative vaginal deliveries in each group	2 years
Number of chorioamnionitis cases in each group	2 years
Number of patients that required oxytocin administration in each group	2 years
Number of vaginal deliveries within 24 hours in each group	2 years
Number of babies that required neonatal intensive care unit (NICU) admission in each group	2 years
Number of babies that had an arterial pH <7 in each group	2 years
Number of babies that had an APGAR score <7 at 5 minutes	2 years
Number of patients that required an epidural in each group	2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026